candidate is responsible for the complete preparation, including but not
limited to, the writing, reviewing and editing of protocols and protocol
amendments, Investigator’s Brochures (IBs) and IB updates, clinical study
reports (CSRs), briefing books, and Summary Modules for Regulatory Submissions.
As a content expert, this position has a significant understanding of
regulatory requirements and ICH guidelines (including E3 and E6), and knowledge
of document management systems.
· Author clinical regulatory documents with minimal input from functional area experts.
· Lead the writing activities, including management of document review cycles and cross-functional collaboration with clinical development, biostatistics, clinical operations, pharmacovigilance, regulatory, project management, and quality assurance.
· Provide input on cross-functional deliverables, as appropriate, including review of key contributing documents, such as the mock/shell Table, Figures, and Listings (TFLs) and Statistical Analysis Plan.
· Participate in the planning and negotiation of timelines.
Serve as a subject matter expert,
representing Medical Writing on cross-functional teams.
· Minimum 5 years of experience with a Master’s of Science degree, PharmD, PhD, or MD preferred; or Minimum 7 years of experience with a Bachelor's degree in Life Sciences or related field.
· Regulatory medical writing experience (INDs, NDAs, PIP, Background packages, Briefing Books, clinical protocol, clinical study report, etc) is required; experience in Neurosciences or pediatric clinical program development is highly preferred.
· Must demonstrate a high-quality writing style in the English language and have the ability to independently interpret and present scientific and clinical data, and to understand statistical methods and analysis plans.
· Exceptional organizational and project planning skills.
· Strong interpersonal skills and the ability to negotiate and influence in a cross-functional environment to achieve results.
· Must be able to manage multiple and varied programs with competing and aggressive timelines, prioritize activities, and be able to succeed in a fast-paced environment.
· Dynamic, self-starter with strong influential skills and be adaptable to change.
· Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems.
· Familiar with style rules from the American Association Manual of Style, 10th Edition.
· Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace